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Intra-arterial Hepatic Beads Loaded With Irinotecan With Concomitant Chemotherapy With FOLFOX in Patients With Colorectal Cancer With Unresectable Liver Metastases: a Phase II Multicenter Study


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer With Non Resectable Hepatic Metastasis

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Trial Information

Intra-arterial Hepatic Beads Loaded With Irinotecan With Concomitant Chemotherapy With FOLFOX in Patients With Colorectal Cancer With Unresectable Liver Metastases: a Phase II Multicenter Study


Inclusion Criteria:



- Histologically proven colorectal adenocarcinoma,

- Liver metastases radiologically or histologically proven

- At least one measurable liver lesions by RECIST v1.1

- Age ≥ 18 years

- WHO Index < or = 2

- Life expectancy ≥ 3 months

- No extrahepatic disease except lung nodules if number < or = 3 and size < 10 mm each

- Healthy liver <60%

- Primary tumor resected or still in place

- No prior chemotherapy for metastases treatment (except a perioperative chemotherapy,
if the last cycle was administered at least 12 months ago)

- Adjuvant chemotherapy after resection of the primary authorized if the last cycle was
administered at least 12 months ago

- Normal hepatic function: total bilirubin ≤ 1.5 N; AST ≤ 5N; ALT ≤ 5N and PAL ≤ 5N

- TP ≥ 60%

- Adequate hematologic function: ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, Hb ≥ 9g/dl

- Good renal function: creatinine clearance ≥ 60 mL / min

- No cardiac dysfunction: no cardiovascular events in the last 6 months or no NYHA ≥ 2

Exclusion Criteria:

- Patient eligible for curative treatment (resection and / or radiofrequency ablation)
by a multidisciplinary decision (including the opinion of a liver surgeon)

- Pregnant or lactating woman or patients of both sexes and of childbearing age not
using adequate contraception

- History of cancer, except skin cancer (other than melanoma), carcinoma in situ of the
cervix uteri treated curative. Other cancers treated with curative intent are
permitted provided they did not relapse over the last 5 years

- Peripheral neuropathy

- Inflammatory Bowel Diseases

- Intestinal obstruction

- Chronic liver disease (viral, alcoholic or metabolic)

- Immune Deficiency Syndromes (history of transplantation, infection with HIV)

- Known to have contraindications to 5FU, oxaliplatin, folinic acid, irinotecan or to
contrast products

- Patients with known contraindications against hepatic embolization procedures:

Presence of biliary-digestive anastomosis or biliary stent Cruoric or tumor thrombosis of
the portal vein

- Patient who for psychological, social, family or geographical reasons could not be
followed up regularly

- Legal disability (persons deprived of liberty or under guardianship)

- Patient is not affiliated to a social security scheme

- Participation in another concurrent study investigating the effect of treatment and
this until 4 weeks after the end of the concurrent study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 9 months

Outcome Time Frame:

at 9 months after inclusion

Safety Issue:

No

Principal Investigator

Julien TAIEB, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fédération Francophone de Cancérologie Digestive

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

FFCD 1201 DEBIRI

NCT ID:

NCT01839877

Start Date:

May 2013

Completion Date:

July 2017

Related Keywords:

  • Colorectal Cancer With Non Resectable Hepatic Metastasis
  • Metastatic colorectal Cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

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